Rivaroxaban, Another New Oral Anticoagulant Approved

On July 1, the FDA approved rivaroxaban (Xarelto), an oral once daily anticoagulant for prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery. This is the second new oral anticoagulant approved within the past year, after over 50 years with warfarin (Coumadin) as the only choice. The drug is approved for use at a 10 mg dose, once a day for 35 days following hip replacement and for 12 days following knee replacement.
Rivaraxaban is also being developed for the prevention of stroke in patients with atrial fibrillation. Rivaroxaban was as effective as warfarin for preventing stroke in patients with Afib and boasted a slightly better safety profile in the ROCKET-AF trial, which is due to be published this year. Approval for stroke prevention is expected.
Rivaroxaban represents a different class of anticoagulant than the previously approved dabigatran (Pradaxa). Rivaroxaban is a factor Xa inhibitor.FDA NEWS RELEASE